Beacon Hill
Quality Control Chemist
Beacon Hill, Grand Haven, Michigan, United States, 49417
SummaryUnder the direction of laboratory management, this individual performs tests, assays and measurements of raw materials, in-process samples, finished products and stability samples. This position is responsible for the day-to-day operation of the Chemistry Laboratory and other quality control functions with a Chemistry Lab context.Essential Duties and
ResponsibilitiesMaintain detailed and up to date documentationPerform routine testing of finished products, raw materials, stability samples and in-house facility samplesPrepare reagents and solutions in accordance with standard operating proceduresProvide timely and high-quality data reports that document test resultsInterface, maintain, and populate the LIMS system as neededPerform sampling of the RO and DI water systems as neededComposite finished products for microbiology/chemistry testingRetain raw materials and finished products as requiredClean laboratory glassware and containers as neededAssist with additional testing for R&D, OOS and deviation investigations when requiredMaintain compliance to current standard operating procedures (SOPs) and current Good Manufacturing Practices (cGMP)Prepare and send samples to outside laboratories for testing as neededProvide on-call coverage for non-scheduled work as neededPerform other duties, as assigned.
Education, Skills and Experience· Bachelor’s degree in Chemistry or a related field.· Experience in a Pharmaceutical laboratory testing environment preferred.Knowledge of cGMPs and good documentation practicesGood analytical technique and instrumentation skillsWell-developed interpersonal skillsDemonstrated ability to work independently with a strong sense of urgencyStrong organizational skills with an attention to detail· Ability to use pH/conductivity meter, Karl Fischer, HPLC, UPLC, FTIR, Ro-Tap, Microtrac, ICP-OES and other related instrumentationProficient in Microsoft Office Word, Excel and OutlookFamiliarity with Empower 3 Chromatography Data Software and BlazeLIMS Data System
ResponsibilitiesMaintain detailed and up to date documentationPerform routine testing of finished products, raw materials, stability samples and in-house facility samplesPrepare reagents and solutions in accordance with standard operating proceduresProvide timely and high-quality data reports that document test resultsInterface, maintain, and populate the LIMS system as neededPerform sampling of the RO and DI water systems as neededComposite finished products for microbiology/chemistry testingRetain raw materials and finished products as requiredClean laboratory glassware and containers as neededAssist with additional testing for R&D, OOS and deviation investigations when requiredMaintain compliance to current standard operating procedures (SOPs) and current Good Manufacturing Practices (cGMP)Prepare and send samples to outside laboratories for testing as neededProvide on-call coverage for non-scheduled work as neededPerform other duties, as assigned.
Education, Skills and Experience· Bachelor’s degree in Chemistry or a related field.· Experience in a Pharmaceutical laboratory testing environment preferred.Knowledge of cGMPs and good documentation practicesGood analytical technique and instrumentation skillsWell-developed interpersonal skillsDemonstrated ability to work independently with a strong sense of urgencyStrong organizational skills with an attention to detail· Ability to use pH/conductivity meter, Karl Fischer, HPLC, UPLC, FTIR, Ro-Tap, Microtrac, ICP-OES and other related instrumentationProficient in Microsoft Office Word, Excel and OutlookFamiliarity with Empower 3 Chromatography Data Software and BlazeLIMS Data System